FDA 510(k) Applications Submitted by EDWARDS LIFESCIENCES, LLC

FDA 510(k) Number Submission Date Device Name Applicant
K152980 10/09/2015 Flo Trac sensor, Volume View sensor Edwards Lifesciences, LLC
K191089 04/24/2019 Edwards Pressure Cable Edwards LifeSciences, LLC
K190205 02/04/2019 HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module Edwards Lifesciences, LLC
K180881 04/04/2018 HemoSphere Advanced Monitor, HemoSphere Pressure Cable Edwards Lifesciences, LLC
K163381 12/01/2016 HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable Edwards Lifesciences, LLC
K192058 08/01/2019 EV1000 Clinical Platform NI, EV1000 Clinical Platform Edwards Lifesciences, LLC
K182245 08/20/2018 EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System Edwards Lifesciences, LLC
K172660 09/05/2017 Duravess bovine pericardial vascular patch Edwards Lifesciences, LLC
K190130 01/28/2019 The ClearSight finger cuffs Edwards Lifesciences, LLC
K160645 03/07/2016 PreSep Oligon Oximetry Catheter EDWARDS LIFESCIENCES, LLC
K152633 09/15/2015 Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe EDWARDS LIFESCIENCES, LLC
K160084 01/15/2016 Swan Ganz Catheters Edwards Lifesciences, LLC
K171996 07/03/2017 TruWave Disposable Pressure Transducer Edwards Lifesciences, LLC
K160552 02/29/2016 EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform EDWARDS LIFESCIENCES, LLC
K181684 06/26/2018 VAMP Plus Venous/Arterial Blood Management Protection System Edwards Lifesciences, LLC
K173586 11/20/2017 VAMP Venous/Arterial Blood Management Protection System Edwards Lifesciences, LLC

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